Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-01-07 @ 4:07 PM
Study NCT ID:
NCT06473792
Status:
COMPLETED
Last Update Posted:
2024-08-02
First Post:
2024-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Probiotic Toothpaste and Regular Toothpaste on Plaque Levels of Orthodontic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058225', 'term': 'Plaque, Amyloid'}, {'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'For reexamination at T1, the investigators were blinded to the intervention.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2024-06-19', 'studyFirstSubmitQcDate': '2024-06-19', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plaque Index Simplified', 'timeFrame': 'Before and three weeks after bonding', 'description': 'Number of sites with plaque/ Number of sites evaluated x 100'}, {'measure': 'Gingival Index', 'timeFrame': 'Before and three weeks after bonding', 'description': 'Gingival Index measures gingival condition of the marginal and interproximal tissues (mesial, lingual, distal, facial) separately on the basis of 0 to 3 with 0=Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Plaque', 'Gingivitis', 'Probiotics'], 'conditions': ['Plaque']}, 'referencesModule': {'references': [{'pmid': '39476739', 'type': 'DERIVED', 'citation': 'Tahir K, Barakaat AA, Shoukat Ali U, Fida M, Sukhia RH. Effect of probiotic toothpaste and regular toothpaste on gingival health and plaque levels of adult orthodontic patients - An open label randomized controlled trial. Int Orthod. 2025 Mar;23(1):100938. doi: 10.1016/j.ortho.2024.100938. Epub 2024 Oct 30.'}]}, 'descriptionModule': {'briefSummary': 'This study is set to determine the improvement in plaque levels utilizing Plaque Index Simplified scores in orthodontic patients using probiotic toothpaste and regular toothpaste.\n\nIt will further analyze the mean difference in oral hygiene scores between metal and ceramic brackets in regular toothpaste and probiotic toothpaste groups.', 'detailedDescription': 'Probiotic toothpaste is formulated to introduce beneficial bacteria into the oral cavity, promoting a balanced microbiome and inhibiting the growth of pathogenic bacteria. Previous research suggests that probiotics can reduce plaque formation, gingival inflammation, and pathogenic bacterial load. By potentially improving the oral microbiome, probiotic toothpaste could offer a superior alternative to standard toothpaste for maintaining oral hygiene in orthodontic patients. Metal and ceramic brackets differ not only in aesthetics but also in their interaction with the oral environment. Ceramic brackets are more brittle and can be more prone to plaque accumulation due to their rougher surface compared to metal brackets. This study will determine the improvement in plaque levels utilizing Plaque Index Simplified scores in orthodontic patients using probiotic toothpaste and regular toothpaste.\n\nIt will further determine the mean difference in oral hygiene scores between metal and ceramic brackets in regular toothpaste and probiotic toothpaste groups.\n\nPlaque will be assessed using plaque disclosing tablets before the bonding (T1) and 3 weeks after the bonding (T2). The data will be collected on Plaque Index Simplified chart. Eligible participants will be randomly allocated to one of the two groups.\n\nGroup A (Control): Participants will be advised to use regular toothpaste twice a day for 3 weeks after the bonding. A standard toothpaste and brushing technique will be conveyed to all the participants.\n\nGroup B (Intervention): Participants will be advised to use a Probiotic toothpaste twice a day for 3 weeks after the bonding. A probiotic toothpaste and brushing technique will be conveyed to all the participants.\n\nThe total sample size for each group would be 26. Since this study has 2 groups, a total number of 52 (N) will be required. Group 1: Regular toothpaste and Group 2: Probiotic toothpaste.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who will be initiating their orthodontic treatment by bonding of metal or ceramic brackets\n* Patients age between 18 - 50 years\n* Patients without any mental and physical disability or craniofacial disorders\n* Patients without enamel or dentin dysplasia\n* Patients not taking medications affecting plaque accumulation such as antibiotics or antibacterial mouth rinses\n* Patients without periodontal disease or dental caries at the study onset\n* Patients willing to follow-up after 3 weeks\n\nExclusion Criteria:\n\n* Patients with neurological mental deficits or otherwise medically compromised\n* Patients with past history of dental trauma or craniofacial syndromes\n* Patients who are smokers\n* Those patients who are already continuing their orthodontic treatment\n* Patients with poor oral hygiene'}, 'identificationModule': {'nctId': 'NCT06473792', 'briefTitle': 'Effect of Probiotic Toothpaste and Regular Toothpaste on Plaque Levels of Orthodontic Patients', 'organization': {'class': 'OTHER', 'fullName': 'Aga Khan University'}, 'officialTitle': 'Effect of Probiotic Toothpaste and Regular Toothpaste on Plaque Levels of Orthodontic - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2023-7853-26493'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Colgate Maximum Cavity Protection (Control)', 'description': 'Participants will be advised to use regular toothpaste twice a day for 3 weeks after the bonding. A regular toothpaste and a standard brushing technique will be conveyed to all the participants.'}, {'type': 'EXPERIMENTAL', 'label': 'Probiotic Toothpaste Group', 'description': 'Participants will be advised to use a Probiotic toothpaste twice a day for 3 weeks after the bonding. A probiotic toothpaste and a standard brushing technique will be conveyed to all the participants.', 'interventionNames': ['Other: Probiotic Toothpaste']}], 'interventions': [{'name': 'Probiotic Toothpaste', 'type': 'OTHER', 'otherNames': ['PerioBiotic Toothpaste - Dental Probiotic Tooth Paste'], 'description': 'Composition: Main - Water, calcium carbonate, calcium glycerophosphate, glycerin, xylitol, sodium bicarbonate, sweet fennel oil (Foeniculum vulgare), carrageenan, maltodextrin, Dental-Lac (Lactobacillus paracasei), potassium sorbate, yucca (Y. filamentosa) powder, stevia leaf extract (Eupatorium rebaudiana bertoni), zinc chloride.\n\nUsage: This is mint flavored toothpaste containing Lactobacillus paracasei which has demonstrated the ability to help address harmful strains of oral flora, and promotes the maintenance of a healthy teeth and gums. The participant will be instructed to brush with it twice daily.', 'armGroupLabels': ['Probiotic Toothpaste Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24700', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Aga Khan University', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Mubassar Fida, FCPS, MCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aga Khan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanza Tahir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Dr. Kanza Tahir', 'investigatorFullName': 'Kanza Tahir', 'investigatorAffiliation': 'Aga Khan University'}}}}